Monthly Archives: August 2015

Newswise — SILVER SPRING, MD, August 23, 2015 – The Armed Forces Health Surveillance Center (AFHSC) when it joins the Defense Health Agency (DHA) today, and brings its expertise in tracking injuries and illnesses among the service members and conducting global health surveillance among its allies to support U.S. national security interests.AFHSC will operate under DHA’s Public Health Division, which reports to the Healthcare Operations Directorate. DHA, which was established in October, 2013, is responsible for delivering integrated health services to the beneficiaries of the Military Health System (MHS) and driving greater integration of clinical and business processes across the MHS.AFHSC provides integrated health surveillance analysis to Department of Defense policy makers, and military commanders, healthcare providers and public health officers to assist the MHS in shaping their health protection and preventive medicine programs for service members and associated populations.

“We’re excited about joining DHA. The ultimate goal for AFHSC is to make sure that its customers – Department of Defense policymakers, military commanders, public health officers and healthcare providers – have the health surveillance information necessary for them to shape their preventive measures that protect our forces,” said Colonel Michael Bell, who is AFHSC’s Chief. “AFHSC’s mission is to make sure that our military leaders and interagency partners have timely and comprehensive health surveillance data in their hands to make those decisions.”As part of the merger, personnel and health surveillance assets from the U.S. Army Public Health Command, U.S. Air Force School of Aerospace Medicine and the Navy and Marine Corps Public Health Center will join AFHSC as satellites. The satellites and AFHSC will work to share data, and improve the health surveillance products they deliver to those overseeing force health protection and readiness among service members.AFHSC is currently organized in to three sections: Epidemiology and Analysis (E&A), Global Emerging Infections Surveillance (GEIS), and Integrated Biosurveillance.

Amid concerns about the potential of a laboratory insider unleashing a deadly bioterror pathogen on the public, President Obama ordered greater scrutiny of workers with access to the riskiest microbes five years ago. The goal of the resulting regulations was to prevent something like the 2001 anthrax letter attacks — or worse — from happening again.

Federal regulators have secretly threatened to revoke permits to study bioterror pathogens from at least six labs — including those operated by Brigham Young University in Utah, the University of Hawaii-Manoa and the California Department of Public Health — because they failed to take required actions to assess the behavior and trustworthiness of their workers, plus other kinds of safety violations, records obtained by USA TODAY show.

In a letter to Brigham Young University, regulators said last year that they had “significant concerns” whether its lab staff could work with potential bioterror pathogens “in a manner which does not endanger public health and safety.” California’s Health Department lab in Richmond allowed unapproved staff to have key cards that let them into restricted areas and ”failed to address safety issues over the course of the last four years,” regulators told the lab.

DELRAY BEACH, Fla., Aug. 26, 2015 (GLOBE NEWSWIRE) — PositiveID Corporation (“PositiveID” or “Company”) (OTCQB:PSID), a developer of biological detection and diagnostics solutions, announced today that it successfully achieved a new milestone in the development of its Firefly Dx PCR (polymerase chain reaction) prototype pathogen detection system (“prototype system”) with the production of the Company’s first article, molded PCR chips for the Firefly Dx cartridge.The completion of injection-molded PCR chips represents the next stage of product maturity for the Firefly Dx prototype system. This advancement will enable the Company to produce large quantities of PCR chips at a lower cost, thereby enabling higher throughput of testing data and cost-effective field applications. PositiveID will now be able to incorporate and optimize additional assays on its Firefly Dx cartridge with a disposable PCR chip.PositiveID’s Firefly Dx is designed to provide real-time, accurate diagnostic results in a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment, highly trained personnel, and can take hours or even days to provide results. Firefly’s applications include point-of-need, lab-quality, detection of pathogenic organisms; agricultural and food screening in both domestic sectors and developing countries; and detection of biological agents associated with weapons of mass destruction. “We continue to be encouraged by our sustained progress with the development and testing of the Firefly Dx prototype system,” stated William J. Caragol, Chairman and CEO of PositiveID. “This latest milestone is significant because it allows us to make our PCR chips disposable, which, we believe, represents another proof statement that Firefly Dx can fill a critical requirement for point-of-need, rapid, and cost-effective biological detection.”

PositiveID Corp. has entered into a strategic financing agreement that will allow for $2.4 million to be used in the continued testing and development of the Firefly Dx device, the company announced on Monday.

“This funding is critically important for the company as we continue to advance the development of Firefly Dx,” PositiveID CEO and Chairman William Caragol said. “We have already proven our ability to test numerous assays on our Firefly Dx prototype system and deliver lab-quality pathogen detection in under 20 minutes. With this funding, we intend to build upon the significant progress we have made and focus on the next phase of our development with the goal of producing a field-testable unit for the large point-of-need detection market.”

This transaction will provide discounted senior secured convertible promissory notes to the investor, which was not identified in the announcement.

The device is a handheld device that is able to provide identification and detection services. The device utilizes polymerase chain reactions to indicate whether a pathogen or other agents is existent within a sample. Tests have indicated thus far that many results are able to come in within a 20-minute timeframe, and the company aims to be able to match laboratory testing results.

According to the new report from BCC Research, the projected U.S. market for biodefense-related rapid pathogen detection devices is valued at $214.2 million in 2015. The total market is projected to grow at a compound annual growth rate (CAGR) of 8% from 2016 through 2021 and reach $248 million by 2016 and $364 million by 2021.

Wellesley, Mass. (PRWEB) August 14, 2015

Demand for point-of-use devices will accelerate the growth of handheld devices in the U.S. market for biodefense-related rapid pathogen identification and treatments. BCC Research reveals in its new report that the majority of devices used for rapid detection are handheld readers with the ability to read various assays, either by individual pathogen or with several pathogens in one test.

The U.S. market for rapid identification/sensing products is projected to grow from $248 billion in 2016 to $364 billion in 2021, reflecting a five-year compound annual growth rate of 8%.

DELRAY BEACH, Fla., Aug. 12, 2015 (GLOBE NEWSWIRE) — PositiveID Corporation (“PositiveID” or “Company”) (OTCQB:PSID), a developer of biological detection and diagnostics solutions, announced today that it successfully detected methicillin-resistant Staphylococcus aureus (“MRSA”) on its Firefly Dx polymerase chain reaction (“PCR”) breadboard prototype pathogen detection system (“prototype system”) in less than 20 minutes. MRSA is a bacterium that is resistant to the antibiotics commonly used to treat ordinary staph infections, and therefore it is difficult to treat.

Most MRSA infections occur in people who have been in hospitals or other health care settings, in which cases it is known as health care-associated MRSA (HA-MRSA). HA-MRSA infections typically are associated with invasive procedures or devices, such as surgeries, intravenous tubing or artificial joints.

According to a market study published by Transparency Market Research, the global hospital acquired disease testing market is forecast to grow at a CAGR of 19.3% during the period of 2013-2019, and is expected to reach US$7.5 billion by the end of 2019.

The MRSA assay was run on the Firefly Dx prototype system, which the Company is developing to be a handheld, fully automated, lab quality, real-time device able to detect these types of threats. Currently tests are run on large lab equipment and take a minimum of four hours to deliver results. A design advantage of Firefly Dx is that it does not require additional equipment or separate steps for sample preparation and purification, unlike current lab-based equipment, thus reducing time to results as well as cost per test. In addition, there is significantly less chance of sample contamination compared to existing testing methods.

“We are excited by the continued positive results from the ongoing testing and development of our Firefly Dx prototype system,” stated William J. Caragol, Chairman and CEO of PositiveID. “With the increasing prevalence of healthcare associated infections and the increasing number of pathogens that are becoming drug resistant, there is an important need for rapid, cost-effective testing solutions for hospital acquired disease testing.”

DELRAY BEACH, Fla., Aug. 10, 2015 (GLOBE NEWSWIRE) — PositiveID Corporation (“PositiveID” or “Company”) (OTCQB:PSID), a developer of biological detection and diagnostics solutions, announced today that it has been selected to present a poster and exhibit at the 2015 Military Health System Research Symposium (MHSRS) Conference on August 17-20, 2015, at the Marriott Harbor Beach Resort in Fort Lauderdale, FL. PositiveID will showcase its biological detection and diagnostics products, primarily its Firefly Dx, during the conference in Booth #50.The Company’s poster, “Firefly Dx; Point-Of-Care Infectious Disease Detection and Diagnostics,” describes the development of the handheld, point-of-care (POC) diagnostics system for rapid identification of naturally occurring infectious diseases within 20 minutes. The Firefly Dx system uses assay specific, disposable cartridges in conjunction with a handheld device, and is designed to be a cost-effective diagnostic tool capable of easy and rapid onsite analysis against multiple user-defined pathogenic targets of interest.Firefly Dx is designed to provide real-time, accurate diagnostic results in a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment and can take hours or even days to provide results. Firefly’s applications include point-of-need, lab-quality, detection of pathogenic organisms; agricultural and food screening in both domestic sectors and developing countries; and detection of biological agents associated with weapons of mass destruction.

FREDERICK, Md. — The Army’s flagship biodefense laboratory at Fort Detrick in Frederick is getting a new commander and a new focus.

Col. Thomas Bundt assumed command Monday of the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick. He succeeds Col. Erin Edgar, who left for medical reasons earlier this summer. The deputy commander, Col. Brian Gentile, has been acting commander in Edgar’s absence.

The Frederick News-Post reports that the institute is moving away from its longtime focus on vaccine development and toward the development of new drugs to combat disease outbreaks.

For example, the lab is helping develop multiple products aimed at treating Ebola. They include the experimental therapeutic drug ZMapp. The drug was given to U.S. health care workers infected with Ebola in Africa last year.

DELRAY BEACH, Fla., Aug. 04, 2015 (GLOBE NEWSWIRE) — PositiveID Corporation (“PositiveID” or “Company”) (OTCQB:PSID), a developer of biological detection and diagnostics solutions, and GenArraytion Inc., a developer of real-time multiplex PCR (polymerase chain reaction) assays, today announced that they have entered into an agreement to partner and evaluate GenArraytion’s assays on PositiveID’s Firefly Dx PCR breadboard prototype pathogen detection system (“prototype system”).Firefly Dx is designed to provide real-time, accurate diagnostic results in a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment and can take hours or even days to provide results. Firefly’s applications include point-of-need, lab-quality, detection of pathogenic organisms; agricultural and food screening in both domestic sectors and developing countries; and detection of biological agents associated with weapons of mass destruction.GenArraytion’s MultiFLEX Bioassays™ for clinically relevant pathogens and bio-threat agents provide a significant advance in multiplexing flexibility, with up to 20 DNA and/or RNA targets in a single assay panel that can be mixed and matched. They are readily configurable, highly specific and sensitive multiplex PCR assays ready for use in real-time and bead-based end-point platforms. MultiFLEX Bioassays™ are developed for clinical pathogens and veterinary disease agents as well as food or water-borne pathogens and biological threats.Dr. R. Paul Schaudies, CEO of GenArraytion, stated, “We are very interested in the work PositiveID is doing with its Firefly Dx, which could significantly advance the capabilities of the real-time PCR market, and we are pleased to partner with them to test our assays on this exciting and essential point-of-need technology platform.”“GenArraytion’s competencies and real-time PCR assays are first-rate, which is evidenced by their world-class customer base, and we believe our cooperative experience will provide us an opportunity to further advance the development and testing of Firefly Dx,” said Lyle Probst, President of PositiveID.